Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

PHASE3RecruitingINTERVENTIONAL
Enrollment

412

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

September 3, 2026

Conditions
Non-Muscle Invasive Bladder Cancer
Interventions
DRUG

BCG for Therapeutic Use

"Specification: 60 mg (6.0×10\^7 CFU)/vial, each vial contains BCG 60 mg and each mg BCG shall have a count of live bacteria not less than 1.0×10\^6 CFU.~Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h."

DRUG

BCG for Therapeutic Use

"Specification: 60 mg/vial with a count of live BCG bacteria not less than 1.0×10\^6 CFU/mg.~Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h."

Trial Locations (1)

510120

RECRUITING

Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

lead

Chengdu CoenBiotech Co., Ltd

INDUSTRY